Report in vitro studies

This reporting checklist was developed to help researchers report in vitro studies in a structured and transparent way. The checklist is based on requirements and recommendations in relevant OECD test guidelines, as well as the OECD Guidance Document for describing non-guideline in vitro test methods (No 211) and the OECD Guidance Document on Good In Vitro Method Practices (GIVIMP) (No 286). Not all items apply to all studies.

You can download the checklist as an excel file in the menu to the right.

Category

Items to be described

Purpose and aim

Purpose and/or aim of the study.

Endpoints

Endpoints included in the investigation.

Test compound

Name, ID and/or CAS-number.

Source, i.e. manufacturer and batch/lot number.

Purity, including information on contaminants, isomers, etc.

Other relevant information, e.g. radiolabelled.

Stability and homogeneity of the compound in the vehicle under the conditions of use and storage.

Stability in the medium, i.e. sensitivity of the test compond to hydrolysis and/or photolysis.

Solubility.

Temperature for storage.

Vehicle

Type/characteristics.

Justification for choice of vehicle if other than ethanol or DMSO.

Ethical statement

Ethical review permissions, licenses and national or institutional guidelines, as relevant.

Test system

Type of system, e.g. cell line, primary cells, tissue, organ, embryo.

Species and strain (as relevant) of the origin of the cells/tissue/organ.

Source, i.e. provider of the cells/tissue/organ.

Metabolic competence.

The number of cell passages if cell line was used.

Composition of the media, including use of serum, antibiotics, etc.

Incubation temperature, humidity, and CO2 concentration.

Measures taken for avoiding or screening for contamination by mycoplasma, bacteria, fungi and virus.

Administration of test compound

Cell density or number of cells used.

Method for deciding on number of replicates per dose level/concentration or the number of times the experiment was repeated, e.g. power calculations.

Information about controls (negative and positive), are they concurrent, historical, matched, etc.

Duration of treatment e.g. hours, days.

Frequency of administration, e.g. single, repeated or continuous.

The number of replicates per dose level/concentration or the number of times the experiment was repeated.

Methods

Methods should be described in enough detail to allow replication either in the Methods section or in another publication to which a clear reference is made.

Standards followed, such as good cell culture practice, if relevant.

Deviations from SOPs.

The time points for data collection were stated.

Description of the method and how it is relevant to the endpoint being investigated.

Data supporting the reliability and sensitivity of the method, i.e. positive control or historical/previously published data or participation in inter-laboratory calibration/validation programs.

Description of how the effect of the test compound on cytotoxicity was measured.

Description of any apparatus used.

Description of parameters measured.

Detection range, limit of detection and limit of quantification.

Description of blinding of research personnel to the treatment during data collection and analysis, when relevant.

Statistics

Details of statistical methods applied.

Description that shows that the assumptions of the statistical methods used are fulfilled.

Data

Response data by treatment group.

All data relevant to the endpoints investigated, including statistically significant changes and the appropriate measures of precision/variance should be presented in a transparent manner for all treatment groups, including negative (and positive) controls.

Discussion

Description of the dose-response relationships for the measured parameters.

How do the results relate to other research within the relevant field, e.g. are the results supported by other research.

Relevance to humans, e.g. how are the results relevant for human health outcomes or modes of action/key events related to human health outcomes.